The Accuracy of Pulse Oxygen Saturation, Heart Rate, Blood Pressure, and Respiratory Rate Raised by a Contactless Telehealth Portal: Validation Study.

BACKGROUND

The traditional measurement of heart rate (HR), oxygen saturation (SpO), blood pressure (BP), and respiratory rate (RR) via physical examination can be challenging, and the recent pandemic has accelerated trends toward telehealth and remote monitoring. Instead of going to the physician to check these vital signs, measuring them at home would be more convenient. Vital sign monitors, also known as physiological parameter monitors, are electronic devices that measure and display biological information about patients under constant monitoring.

OBJECTIVE

The purpose of this study was to validate the accuracy of the pulse SpO, HR, BP, and RR raised by Docsun Telehealth Portal by comparing it with approved medical devices.

METHODS

This is a noninvasive, self-check, system-based study conducted to validate the detection of vital signs (SpO, HR, BP, and RR) raised by Docsun Telehealth Portal. The input for software processing involves facial screening without any accessories on the face, scanning directly through the software application portal. The participant's facial features are detected and screened for the extraction of necessary readings.

RESULTS

For the validation of HR, SpO, BP, and RR measurements, the main outcomes were the mean of the absolute difference between the respective investigational devices and the reference values as well as the absolute percentage difference between the respective investigational devices and the reference values. If the HR was within ±10% of the reference standard or 5 beats per minute, it was considered acceptable for clinical purposes. The average absolute difference between the Docsun Telehealth Portal and the reference values was 1.41 (SD 1.14) beats per minute. The mean absolute percentage difference was 1.69% (SD 1.37). Therefore, the Docsun Telehealth Portal met the predefined accuracy cutoff for HR measurements. If the RR was within ±10% of the reference standard or 3 breaths per minute, it was considered acceptable for clinical purposes. The average absolute difference between the Docsun Telehealth Portal and the reference values was 0.86 breaths per minute. The mean absolute percentage difference was 4.72%. Therefore, the Docsun Telehealth Portal met the predefined accuracy cutoff for RR measurements. SpO levels were considered acceptable if the average absolute difference between the Docsun Telehealth Portal and the reference values was ±3%. The mean absolute percentage difference was 0.59%. Therefore, the Docsun Telehealth Portal met the predefined accuracy cutoff for SpO measurements. The Docsun Telehealth Portal predicted systolic BP with an accuracy of 94.81% and diastolic BP with an accuracy of 95.71%.

CONCLUSIONS

The results of the study show that the accuracy of the HR, BP, SpO, and RR values raised by the Docsun Telehealth Portal, compared against the clinically approved medical devices, proved to be accurate by meeting predefined accuracy guidelines.